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NCT06056271Recruiting

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

Volta Medical

Start Date

3/19/2024

Completion Date

12/1/2027

Summary

Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: 1. Patients 21 years of age or older who is: * indicated for AF ablation or * Who has received an AF-ablation with the past 24 months where VX1 was used or 2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines 3. Patients must be able and willing to provide written informed consent to participate in the clinical trial Exclusion Criteria: 1. Patients not indicated or were not indicated for catheter ablation according to current guidelines 2. Patients with AF secondary to an obvious reversible cause 3. Patients who are or may potentially be pregnant 4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug

Interventions

DEVICE

AF Ablation

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Conditions

Atrial Fibrillation

Locations

Endeavor Health

Evanston, Illinois 60201

United States

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas 66211

United States

Northwell Health

New York, New York 10075

United States

Ohio State University

Columbus, Ohio 43210

United States